99-30084. Obstetric and Gynecologic Devices; Reclassification and Classification of Medical Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures; Technical Amendment

[Federal Register Volume 64, Number 222 (Thursday, November 18, 1999)]
[Rules and Regulations]
[Page 62977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30084]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. 97N-0335]


Obstetric and Gynecologic Devices; Reclassification and 
Classification of Medical Devices Used for In Vitro Fertilization and 
Related Assisted Reproduction Procedures; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
obstetrical and gynecological device regulations regarding assisted 
reproductive microscopes and microscope accessories. This action is 
being taken to ensure accuracy and clarity in the agency's regulations.

EFFECTIVE DATE: November 18, 1999.
FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy 
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-7010.

SUPPLEMENTARY INFORMATION: FDA has discovered that an error was 
incorporated into the agency's obstetrical and gynecological devices 
regulations for assisted reproductive microscopes and microscope 
accessories. In an amendment to 21 CFR part 884, which added 21 CFR 
884.6190 and published on September 10, 1998 (63 FR 48428), a sentence 
stating that the device is exempt from the premarket notification 
procedures was inadvertently included in paragraph (a) instead of 
paragraph (b). This document corrects that error. Publication of this 
document constitutes final action under the Administrative Procedure 
Act (5 U.S.C. 553). FDA has determined that notice and public comment 
are unnecessary because this amendment is nonsubstantive.

List of Subjects in 21 CFR Part 884

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
884 is amended as follows:

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

    1. The authority citation for 21 CFR part 884 continues to read as 
follows:

    Authority: 21 CFR U.S.C. 351, 360, 360c, 360e, 360j, 371.
    2. Section 884.6190 is amended by removing the last sentence in 
paragraph (a), and paragraph (b) is revised to read as follows:


Sec. 884.6190   Assisted reproductive microsopes and microscope 
accessories.

* * * * *
    (b) Classification. Class 1. This device is exempt from the 
premarket notification procedures in subpart E of part 807 of chapter 
subject to limitation in Sec. 884.9.

    Dated: November 4, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-30084 Filed 11-17-99; 8:45 am]
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